A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B

Phase 2

Completed

• Conditions: HBV
• Interventions: Other: placebo; Drug: Antroquinonol

• Registration Number: NCT03625102
• Lead Sponsor: Golden Biotechnology Corporation

Brief Summary

Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC).Existing treatments for hepatitis B infection have various side-effects including renal toxicity and drug resistance or failure.

Detailed Description

Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC). Those carriers in China account for 33% of all chronic carriers globally. A big epidemiological study of patients with chronic hepatitis B has revealed that baseline HBV DNA level or cirrhosis is an independent predictor for the occurrence of HCC.

Antroquinonol is a new chemical entity isolated from the mycelium of Antrodia camphorata, which showed interesting anticancer and anti-inflammatory activities.Previous studies have indicated that signaling molecules, such as PI3K, AMPK, and mTOR, participate in Antroquinonol-induced cancer cell death, whereas Nrf2 and NF-kB are involved in the anti-inflammatory effects of Antroquinonol. Moreover, we also found the administration of Antroquinonol also differentially modulated T cell activity and reduced IL-18 production, but enhanced the activation of Nrf2 and, thus, suppressed oxidative stress by animal studies. These results demonstrate the potential applications of Antroquinonol in treating hepatitis B.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Chronic HBV infection patients between the ages of 20 and 75 years with serum hepatitis B surface antigen(HBsAg) positivity for more than 6 months
2. BMI≦35
3. HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.
4. AST or ALT≧25 IU and ALT<5xULN
5. Female subject must use effective methods of contraception.
6. No abnormal finding of clinical relevance
7. Written informed consent

Exclusion Criteria

1. Evidence of hepatic decompensation such as:

   1. Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds
   2. Total bilirubin of 2 times the upper limit of normal
   3. FIB-4 of 3.25 or greater

2. Abnormal hematological and biochemical parameters at screening A、 White blood cell count less than 2500 cells/uL B、 Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects) C、 Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females D、 Estimated GFR less than 50 mL/min

3. Suspected or confirmed liver diseases from etiologies other than HBV (such as alcohol, toxin, drug, shock, acute viral hepatitis A or E), co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis delta virus, prior antiviral treatment with NUCs or interferon, and recent immunosuppressive therapy (including chemotherapy and systemic corticosteroid).

4. Immunodeficiency disorders or severe autoimmune disease

5. Severe pulmonary disorders or significant cardiac diseases

6. Gastrointestinal disorder with post-operative condition that could interfere with drug absorption

7. Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

8. Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence)

9. Solid organ transplantation

10. Current drug or alcohol abuse

11. Pregnancy or lactation

12. Under hepatitis B antiviral or interferon treatment within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo capsule, 2 capsules placebo, twice a day
Antroquinonol 50 mg PO BID	placebo	Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
Antroquinonol 50 mg PO BID	Antroquinonol	Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
Antroquinonol 100 mg PO BID	Antroquinonol	Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.

Primary Outcome Measures

Name	Time	Method
Percentage	12 weeks	The percentage improvement between baseline and day 85 in quantitative HBsAg.

Secondary Outcome Measures

Name	Time	Method
IU/mL	4 week	Sserum hapatitis B virus DNA level
score	12 week	The Fibrosis-4 score helps to estimate the amount of scarring in the liver
Unit/L	4 week	Glutamic Oxaloacetic Transaminase
Unit /L	4 week	Glutamic Pyruvic Transaminase

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan